Quick answers
- What is Naropin?
- Naropin is a brand name of Ropivacaine hydrochloride, a prescription medicine. The FDA NDC Directory lists 5 Naropin products in 4 strengths and forms.
- Who makes Naropin?
- Fresenius Kabi USA holds the FDA application for Naropin (NDA020533, approved September 24, 1996). 1 other company (repackagers or distributors) also list Naropin products.
- Is there a generic or store brand of Naropin?
- Yes. The FDA NDC Directory lists 37 other products with the same active ingredients, strength and form as a Naropin product, 37 of them generic. Ask your pharmacist whether one is right for you.
- Has Naropin been recalled?
- FDA enforcement reports list 1 recall of Naropin products; the newest started July 16, 2026. A recall usually concerns specific lots, not every product.
What Naropin is
Each Naropin product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Ropivacaine hydrochloride · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| ropivacaine hydrochloride 10 mg/mL injection, solution (epidural) | Naropin | 6 products, 4 companies | DailyMed |
| ropivacaine hydrochloride 2 mg/mL injection, solution (epidural, infiltration) | Naropin | 19 products, 11 companies | DailyMed |
| ropivacaine hydrochloride 5 mg/mL injection, solution (epidural, infiltration, perineural) | Naropin | 10 products, 7 companies | DailyMed |
| ropivacaine hydrochloride 7.5 mg/mL injection, solution (epidural, perineural) | Naropin | 2 products, 2 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Ropivacaine hydrochloride →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA020533 | Fresenius Kabi USA | September 24, 1996 | 5 |
Companies that list Naropin
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Naropin products.
- Fresenius Kabi USA, LLC4 products
- Henry Schein, Inc.1 product
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
July 16, 2026 · Class II · Ongoing · D-0727-2026
Presence of Particulate Matter: Hair was found in products
Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-five, 20 mL Single-Dose Vials, Rx only, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-286-23; NDC Vial: 63323-286-0 — Fresenius Kabi USA, LLC
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.